AAMI TIR29-2012/(R)2017
Guide for process characterization and control in radiation sterilization of medical devices
医疗器械辐射灭菌过程特性和控制指南
2012-12-31
BS ISO 14470-2011
Food irradiation. Requirements for the development, validation and routine control of the process of irradiation using ionizing radiation for the treatment of food
食物辐照 使用电离辐射处理食品的辐照过程的开发、验证和常规控制要求
2012-01-31
BS EN ISO 11137-1-2015+A2-2019
Sterilization of health care products. Radiation-Requirements for development, validation and routine control of a sterilization process for medical devices
医疗保健产品的消毒 辐射
2019-11-27
GOST ISO 14470-2014
Радиационная обработка пищевых продуктов. Требования к разработке, валидации и повседневному контролю процесса облучения пищевых продуктов ионизирующим излучением
食物辐射 使用电离辐射照射食品过程的开发 验证和常规控制要求
2014-08-29
ISO 14470-2011
Food irradiation — Requirements for the development, validation and routine control of the process of irradiation using ionizing radiation for the treatment of food
食品辐照——食品处理用电离辐射辐照过程的开发、验证和常规控制要求
2011-11-23
AAMI/ISO 14937-2009/(R)2013
Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
医疗保健产品的灭菌.医疗器械用灭菌剂特性和灭菌过程的开发、验证和常规控制的一般要求
2009-10-14
KS P ISO 14937
의료용품의 멸균 — 의료기기용 멸균제 특성 분석 및 멸균 공정의 개발, 유효성 확인, 정기 관리에 대한 일반 요구사항
保健产品的灭菌 - 杀菌剂的一般要求以及医疗器械灭菌过程的开发 验证和日常控制
2018-11-05
BS EN ISO 14937-2009
Sterilization of health care products. General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
医疗保健产品的消毒 医疗器械用杀菌剂的特性、杀菌过程的开发、验证和常规控制的一般要求
2010-03-31
KS P ISO 14937
의료제품의 멸균 — 의료기기용 멸균제 특성 분석과 멸균 공정의 개발, 유효성 확인, 일상관리에 대한 일반 요구사항
卫生保健产品灭菌.灭菌剂特性和医疗器械灭菌过程的开发、验证和常规控制的一般要求
2023-12-28
GB/T 19974-2018
医疗保健产品灭菌 灭菌因子的特性及医疗器械灭菌过程的开发、确认和常规控制的通用要求
Sterilization of health care products—General requirement for characterization of a sterilization agent and the development,validation and routine control of a sterilization process for medical devices
2018-05-14
ISO 14937-2009
Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
保健品灭菌——医疗器械用杀菌剂特性和杀菌过程的开发、验证和常规控制的一般要求
2009-10-14
KS P ISO 11137-1
의료제품의 멸균 — 방사선 — 제1부: 의료기기 멸균 공정의 개발, 유효성 확인 및 일상 관리에 대한 요구사항
保健产品的灭菌 - 辐射 - 第1部分:医疗器械灭菌过程的开发 验证和日常控制要求
2019-11-25
AS/NZS ISO 11137.1-2006
Sterilization of health care products - Radiation, Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
医疗保健产品的灭菌辐射第1部分:医疗器械灭菌过程的开发、验证和常规控制要求
2006-12-19
KS P ISO 11137-1
의료제품의 멸균 ─ 방사선 ─ 제1부: 의료기기 멸균 공정의 개발, 유효성 확인 및 일상 관리에 대한 요구사항
保健品灭菌─ 辐射─ 第1部分:医疗器械灭菌过程的开发、验证和常规控制要求
2022-12-28
GOST ISO 11137-1-2011
Стерилизация медицинской продукции. Радиационная стерилизация. Часть 1. Требования к разработке, валидации и текущему контролю процесса стерилизации медицинских изделий
保健产品的灭菌 辐射 第一部分医疗器械灭菌过程的开发 验证和常规控制要求
2011-11-29
ISO 11137-1-2025
Sterilization of health care products — Radiation — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
保健产品的灭菌 辐射 第1部分:医疗器械灭菌过程的开发、验证和常规控制的要求
2025-04-02
UNE-EN ISO 14937-2010
Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
医疗保健产品的灭菌.医疗器械用灭菌剂特性和灭菌过程的开发、验证和常规控制的一般要求（ISO 14937-2009）
2010-05-26
UNE-EN ISO 11137-1-2007
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006)
医疗保健产品的灭菌辐射第1部分:医疗器械灭菌过程的开发、验证和常规控制要求
2007-03-14
AAMI/ISO 11137-1-2006/(R)2015 & A1-2003 & A2-2019(Consolidated Text)
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices, Includes A1:2013 & A2:2019
医疗保健产品的灭菌-辐射-第1部分:医疗器械灭菌过程的开发、验证和常规控制要求 包括A1:2013和A2:2019
2013-12-30
AAMI/ISO 14160-2011/(R)2016
Sterilization of health care products - liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - requirements for characterization, development, validation and routine control of a sterilization process for medical devices
医疗保健产品的灭菌.利用动物组织及其衍生物的一次性医疗器械用液体化学灭菌剂.医疗器械灭菌过程的特性、开发、验证和常规控制要求
2011-12-05